March 23, 2010 - See Notice NOT-OD-10-069 This notice terminates the Institutional Research Training and Institutional Research Career Development Programs listed below because they provide application instructions for paper submissions using the PHS 398 forms.

Purpose.The purpose of this
announcement is to invite applications for U.S. and developing country
institutions for programs to provide infectious disease (excluding
HIV/AIDS) research training to scientists and health professionals in
order to build sustainable research capacity at institutions in low- and
middle-income endemic countries.

Mechanism of Support.This FOA will utilize the D43grant
mechanism

Funds
Available and Anticipated Number of Awards. The
total amount to be awarded is expected to be between $600,000 and $1
million per year, depending on availability of funds. The anticipated
number of awards is four to six new and competitive renewal awards, one to
two planning grants, and one to two supplemental awards each year.

Budget
and Project Period.An
applicant for a new Global Infectious Disease Research Training Program award
may request a project period of up to five years and a budget for direct costs
of up to $138,000 per year maximum. An applicant submitting a renewal
application may request a project period of up to five years and a budget for
direct costs up to $184,000. An applicant for a revision to a current Global
Infectious Disease Research Training award may request up to $46,000 per year
direct costs for up to the number of years remaining in the award. A
developing country applicant for a planning grant may request up to $23,000
direct costs for one year.

Eligible Institutions/Organizations. Institutions/organizations
listed in Section III, 1.A. are eligible to apply. Eligible organizations include
non-profit public or private research institutions in the U.S. or developing countries.

Eligible Project Directors/Principal
Investigators (PDs/PIs). Individuals with the skills, knowledge, and
resources necessary to carry out the proposed research are invited to work
with their institution/organization to develop an application for support.
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH
support. Eligible PDs/PIs include individuals from U.S. or
developing country institutions, with a demonstrable history of research
collaboration with the proposed partner institution, and who are
designated as the PD/PI on at least one active infectious disease research
grant (with at least 18 months of support remaining at the time of
application) from the NIH or other national or international granting
organizations.

Number of PDs/PIs. More than one
PD/PI, or multiple PDs/PIs, may be designated on the application. One
collaborator from each country involved may be listed as a PD/PI on the
application.

Number of Applications. Applicants may submit more than one application, provided that each
application is scientifically distinct.Only one application
may be submitted from an institution proposing research training on a
particular infectious disease or working at a particular developing
country institution.

Resubmissions.Resubmission applications will be accepted. Such
application must include an Introduction addressing the previous peer
review critique (Summary Statement).

Infectious
diseases continue to impose a tremendous health burden in resource-poor
countries throughout the world, claiming millions of lives annually and
inflicting severe morbidity that results in significant losses in economic
productivity and social progress. Attempts to control infectious diseases
endemic to developing countries suffer due to an incomplete understanding of
the pathogens, their disease manifestations and transmission mechanisms,
inadequate preventive measures and interventions, and inadequate health
services and disease control efforts. A major barrier to improved research,
treatment and control of infectious diseases is the scarcity of scientists and
health professionals in endemic countries with relevant infectious disease
research knowledge and expertise.

The purpose of this announcement is to invite applications
from U.S. and developing country institutions to train or expand the
capabilities of scientists and health professionals from developing countries
to engage in infectious diseases (excluding HIV/AIDS) research. Proposals are
requested for innovative, collaborative research training programs that would
contribute to the long-term goal of building sustainable research capacity in
endemic infectious diseases at developing country institutions. The intent is
to harness scientific knowledge and skills to enhance prevention, treatment and
control of infectious diseases causing major morbidity and mortality in
developing countries. Developing country institutions may also apply for
one-year planning grants to support the development and submission of research
training program proposals in the subsequent year. In addition, ongoing
infectious disease research training awardees may apply for a competing
revision (formerly called supplement) award to
their Global Infectious Disease Research Training awards to expand their
training activities.

FIC will support research-training programs that focus on
building sustainable non-HIV/AIDS infectious disease research capacity at an
institution in an endemic developing country. Sustainable research capacity
depends on building a critical mass of scientists and health professionals with
in-depth scientific expertise and complementary skills that enable the
institution to conduct independent, internationally-recognized infectious
disease research relevant to the health priorities of their countries. FIC will
support research-training programs that focus on major endemic or
life-threatening emerging infectious diseases, neglected tropical diseases,
significant co-infections of HIV/AIDS patients or the relationship of
infectious disease to non-communicable disease conditions of poverty in
developing countries. Research training programs should be structured to
provide an appropriate balance of short- and long-term training, degree and
non-degree training opportunities for participants from developing country
institutions designed overall to build sustainable research capacity in
partnership with ongoing U.S. research activities. It is expected that each
grant awarded will:

The Fogarty International Center expects to provide
from between $600,000 and $1 million per year to fund a combination of
four to six new and competitive renewal awards, one to two planning grants
and one to two supplemental awards each year depending on availability of
funds. Future
year amounts will depend on annual appropriations

Awards are expected to be made beginning June 1.

Under this PA, an applicant can submit a new or
renewal award application, a competing revision (formerly
called supplement) application or a developing country applicant
may apply for a one-year research training program planning grant.

1. An applicant
for a new Global Infectious Disease Research Training Program award may request
a project period of up to five years and a budget for direct costs of up to
$138,000 per year maximum.

2. An applicant
submitting a renewal application may request a project period of up to five
years and a budget for direct costs up to $184,000.

3. An applicant
for a revision
(formerly called supplement) award to a current Global Infectious Disease Research Training
award may request up to $46,000 per year direct costs for up to the number of
years remaining in the award.

4. A developing
country applicant for a planning grant may request up to $23,000 direct costs
for one year.

Because
the nature and scope of the proposed research training will vary from
application to application, it is anticipated that the size and duration of
each award will also vary. Although the financial plans of the IC(s) provide
support for this program, awards pursuant to this funding opportunity are
contingent upon the availability of funds.

Facilities
and administrative costs requested by consortium participants are not included
in the direct cost limitation; see NOT-OD-05-004.

The
decision of whether to apply for a grant with a single PD/PI or multiple
PDs/PIs is the responsibility of the investigators and applicant organizations
and should be determined by the scientific goals of the project. Applications
for grants with multiple PDs/PIs will require additional information, as
outlined in the instructions below. The NIH review criteria for approach,
investigators, and environment have been modified to accommodate applications
involving either a single PD/PI or multiple PDs/PIs. When considering multiple
PDs/PIs, please be aware that the structure and governance of the PD/PI
leadership team as well as the knowledge, skills and experience of the
individual PDs/PIs will be factored into the assessment of the overall
scientific merit of the application. Multiple PDs/PIs on a project share the
authority and responsibility for leading and directing the project,
intellectually and logistically. Each PD/PI is responsible and accountable
to the grantee organization, or, as appropriate, to a collaborating
organization, for the proper conduct of the project or program, including the
submission of required reports. For further information on multiple PDs/PIs,
please seehttp://grants.nih.gov/grants/multi_pi.

All
applicants (including all multiple PIs) must be officially listed as the
Principal Investigator (not co-investigator) of at least one active infectious
disease research grant (with at least 18 months of support remaining at the
time of application), from the NIH or other national or international research
support organization, directly relevant to the research training proposed. An
applicant's failure to meet the eligibility criteria by the time of the
application deadline will result in the return of the application without
review or, if reviewed, will preclude FIC from making an award.

One collaborator from each country involved may be listed
as a PD/PI on the application. The first PD/PI listed must be affiliated with
the institution submitting the application and will serve as the contact
PD/PI.

Applicants
may submit a resubmission application, but such application must include an
Introduction addressing the previous peer review critique (Summary Statement).

Applicants may submit a renewal application.

Applicants may submit more than one application, provided
that each application is scientifically distinct. Only
one application may be submitted from an institution proposing research
training on a particular infectious disease or working at a particular
developing country institution.

Types of Trainees:

Applicants should describe the characteristics of the
trainees they plan to recruit for each type of training proposed. Training may
be offered to a wide range of developing country scientists, including
laboratory scientists, clinicians, social scientists, and other health
professionals, as well as technical and administrative staff. The intent of all
training proposed should be to build a critical mass of researchers and support
staff with the combined expertise and skills to conduct independent infectious
disease research. Applicants should provide a description of culturally sensitive
strategies to recruit women and members of minority and socially disadvantaged
populations in the developing country as trainees.

Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or cooperative
agreements. The D&B number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dnb.com/us/. The
D&B number should be entered on line 11 of the face page of the PHS 398
form.

The title and
number of this funding opportunity must be typed on lines 1 and 2 of the face
page of the application form and the YES box must be checked.

Every effort should be made to comply with the
format specifications, which are based upon a standard U.S. paper size of 8.5” x 11” within each PDF.

Funds for up to 8% Facilities and administrative
(F&A) costs (excluding equipment) may be requested. SeeNOT-OD-01-028, March 29,
2001.

Organizations must comply with Federal/NIH
policies on human subjects, animals, and biohazards.

Organizations must comply with Federal/NIH
biosafety and biosecurity regulations. See Section
VI.2., “Administrative and National Policy
Requirements.”

Proposed
research should provide special opportunities for furthering research programs
through the use of unusual talent, resources, populations, or environmental
conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

Applications
with Multiple PDs/PIs

When
multiple PD/PIs are proposed, use the Face Page-Continued page to provide items
3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact
PD/PI” for all communications between the PD/PIs and the agency. The contact
PD/PI must meet all eligibility requirements for PD/PI status in the same way
as other PD/PIs, but has no special roles or responsibilities within the
project team beyond those mentioned above. The contact PD/PI may be changed
during the project period. The contact PD/PI should be listed in block 3 of
Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page
1-Continued. When inserting the name of the PD/PI in the header of each
application page, use the name of the “Contact PD/PI, et. al.” The contact
PD/PI must be from the applicant organization if PD/PIs are from more than one
institution.

All individuals designated
as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI
role in that system (other roles will not give the PD/PI the appropriate access
to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing
Multiple PDs/PIs will be required to include a new section describing the
leadership plan approach for the proposed project.

Multiple
PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new
section of the research plan, entitled “Multiple PD/PI Leadership Plan” must be
included. A rationale for choosing a multiple PD/PI approach should be
described. The governance and organizational structure of the leadership team
and the research project should be described, and should include communication
plans, process for making decisions on scientific direction, and procedures for
resolving conflicts. The roles and administrative, technical, and
scientific responsibilities for the project or program should be delineated for
the PDs/PIs and other collaborators.

If
budget allocation is planned, the distribution of resources to specific
components of the project or the individual PDs/PIs should be delineated in the
Leadership Plan. In the event of an award, the requested allocations may be
reflected in a footnote on the Notice of Award.

Prospective
applicants are asked to submit a letter of intent that includes the following
information:

Descriptive title of proposed research

Name, address, and telephone number of the Principal
Investigator

Names of other key personnel

Participating institutions

Number and title of this funding opportunity

Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.

Applications
must be prepared using the research grant application forms found in the PHS
398 instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and five
signed photocopies in one package to:

Applications must be received on or before the application
receipt/ date(s) described above (Section
IV.3.A.). If an application is received after that date, it will be
returned to the applicant without review.

Upon receipt
applications will be evaluated for completeness by CSR. Incomplete applications
will not be reviewed.

The NIH will not
accept any application in response to this funding opportunity that is
essentially the same as one currently pending initial merit review unless the
applicant withdraws the pending application. The NIH will not accept any
application that is essentially the same as one already reviewed. However, the
NIH will accept a resubmission application, but such application must include
an Introduction addressing the critique from the previous review.

All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants
Policy Statement.

Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or renewal award if such costs: 1) are
necessary to conduct the project, and 2) would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not impair
the grantee's ability to accomplish the project objectives in the approved time
frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)

Allowable
Costs

Applicants
should develop a budget that reflects the resources necessary to implement the
components of the comprehensive developing country research-training plan included
in their application. The budgets may include costs to support the various
types of training proposed (tuition, stipends, salary, travel, per diem) for
trainees and faculty, and costs to support the administration of the program
and grant. Adequate resources to meet U.S. government requirements for training
and training-related research should be included in the budget.

A detailed budget justification should be provided
explaining how requested funds will primarily support developing country
trainees. All expenses related to trainee participation in the program should
be itemized on the PHS Form 398 (NRSA substitute budget pages 4 & 5) in the
appropriate categories. All expenses related to faculty participation in the
program should be itemized on the PHS Form 398 (budget form pages 4 & 5) in
the appropriate categories. The total direct costs of the trainee participation
budget should be identified on PHS Form 398 (budget form pages 4 & 5) in
the "Other" category. The combining of the budget figures will allow
reviewers and FIC staff to review a composite budget of all costs.

Requested Salary Support: The salary for the PI, other
training faculty and administrative staff directly associated with this
research training program must be commensurate with the salary structure and
benefits at the institution where they are employed and within the limits
described at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-033.html. Foreign
collaborators may receive appropriate compensation for their significant
activities on the program, such as recruitment and selection activities, as
well as other program-related roles. The administrative, training or teaching
responsibilities and time commitment for personnel receiving salary should be
thoroughly described. The salary and fringe benefits for the staff at the
grantee institution should not exceed 25 percent of total direct costs.

Trainee Stipends: Trainees may be paid a stipend comparable
to their professional experience in accordance with NRSA levels or grantee
institutional policies while involved in long-term training at the grantee
institution. Current NRSA stipend levels may be used as a guide and are
described on the web site http://grants.nih.gov/training/nrsa.htm.

Tuition, Fees and Health Insurance for Trainees: Funds for
tuition, health insurance and academic fees at the U.S. or foreign institution
may be requested. Programs are encouraged to seek cost-sharing arrangements
with the grantee institutions in order to provide reduced tuition for
trainees.

Network Meetings: Funds to support the attendance of the
Principal Investigator(s) at the annual network meeting for the program in the U.S. may be requested.

Research
Training Plan:In place of the
research plan requested in the PHS 398 application instructions, applicants
should follow the instructions regarding research-training plans for NRSA
applications.

In addition, the following information should be included:

Needs Assessment:Applications should present a detailed assessment of the
needs for the specific infectious disease research training at the developing
country institution and a proposed training plan to address those needs during
the course of a five-year award. The assessment should identify specific gaps
in laboratory, clinical, epidemiological, vector-related, social science, and
operational and health services research expertise, and adjunct skills needed
to address the infectious disease focus of the proposal. The relevance of the
infectious disease focus of the proposed training to the health of the host
endemic country should be explained in detail.

Types of Training:The proposed research-training program may focus on one or
more infectious diseases of major health importance to the developing country
population focus of the proposal. Mentored trainee research may focus on
analyzing the basic mechanisms of host-pathogen interaction, understanding
disease transmission and pathology or developing new interventions, prevention
measures or diagnostic methods, as well as clinical, operational and health
services studies. Trainee research projects may be part of a training faculty
member's peer-reviewed infectious disease research grant funded by NIH or other
research support agencies.

Applicants should describe plans to meet the requirements
related to the protection of human subjects in all training-related research.
All training-related research projects in which trainees are involved under
this award must be peer-reviewed through a Training Advisory Group (see below),
and documented evidence for education in the protection of human subjects for
the trainee, compliance with the required federal citations, and approval from institutional
(or ethical) review boards or committees at applicant and collaborating foreign
institutions, and from the relevant government authority.

Applicants should also provide training in adjunct skills
needed at the host developing country institution to support sustainable
independent research such as the use of scientific literature, scientific
writing and presentation, grant writing, bioinformatics, bioethics, good
clinical practice, biosafety, data management, research administration, the management
of intellectual property and English as a second language, if necessary.

Applicants should propose an appropriate balance of
research training options (degree-related and non-degree training) to match the
needs of the trainees and their developing country institution. Long-term
research training may include studies leading to an advanced degree or a
mentored post-advanced degree experience. Long-term training may include
enrollment in academic courses related to infectious disease research. Short-term
training in short courses, workshops or practical experience of up to several
months in specific research methods or other laboratory, clinical, social
science or field skills for infectious disease research may be proposed in
addition to long-term training. Participants in short-term training must be
involved in research in which the training will be immediately utilized at
developing country institutions. Didactic short courses or workshops on broad
scientific or medical topics not directly relevant to the research training
focus of the program will not be supported.

Training and trainee degrees may be attained at either the U.S. or developing country institution. However, applicants are strongly encouraged to
provide support and mentoring by U.S. and developing country faculty for
trainees to conduct the research related to their training in the developing
country to the greatest extent possible.

Applicants are required to provide all long-term trainees
with training in the responsible conduct of research at either the U.S. or developing country institution. For more information on this provision, see the NIH
Guide for Grant and Contracts (volume 21, number 43 http://grants.nih.gov/grants/guide/notice-files/not92-236.html).
NIH does not require a specific curriculum or format for instruction but the
following areas should be included: conflict of interest, responsible
authorship and institutional policies for handling scientific misconduct, human
subjects, animal studies, data management and data sharing. The inclusion of
international perspectives on these topics is strongly encouraged. The
following information must be provided in the description of your plan: topics
to be covered, format, faculty participating, instructional materials,
frequency and duration of training, and how trainee attendance will be
monitored.

Types of Trainees:Applicants should describe the characteristics of the
trainees they plan to recruit for each type of training proposed. Training may
be offered to a wide range of developing country scientists, including
laboratory scientists, clinicians, social scientists, and other health
professionals, as well as technical and administrative staff. The intent of all
training proposed should be to build a critical mass of researchers and support
staff with the combined expertise and skills to conduct independent infectious
disease research. Applicants should provide a description of culturally
sensitive strategies to recruit women and members of minority and socially
disadvantaged populations in the developing country as trainees.

Trainee Recruitment, Selection and Evaluation:Training plans should also describe in detail each of the
following processes:

Trainee recruitment;

Trainee candidate evaluation and
criteria for selection;

Pre-training orientation;

Trainee mentorship;

Trainee evaluation;

Post-training integration into the
collaborating developing country institution's infectious disease research
activities; and

Dissemination of trainee research
results to the relevant international scientific community and the
clinical or public health sectors of the developing country;

Research Training Faculty and Environment:Applicants should describe the specific roles of U.S. and
developing country training faculty who will be directly involved in the
proposed training, including their developing country training records,
relevant infectious disease research grant support and relevant U.S.-developing
country research collaborations. The application should also include letters
from participating U.S. and developing country faculty stating agreement with
the roles specified in the proposal, as well as their time commitment in the
proposed training program. Pertinent infectious disease research resources and
the educational environment including the options available for distance
learning for the proposed training at the U.S. and developing country
institutions should be described.

Training Advisory Group:A training advisory group composed of expert U.S. and
developing country faculty including a majority who are not directly involved
in mentoring trainees should be established to assist in trainee selection,
scientific review of trainee projects, and evaluation of trainees and training
program progress. Applicants should describe the composition and expertise of
the proposed training advisory group, the specific responsibilities of the
group, and the processes for it to accomplish its responsibilities.

Renewal Applications:Renewal applications should contain detailed information
about previous FIC-supported research training efforts including: a
comprehensive list of all trainees; type and length of training provided in the
U.S. and developing country and the trainee's current position. Applicants
for renewal awards should provide a list of publications in peer-reviewed
scientific journals in which trainee research was supported by their previous
FIC training award, i.e. publications in which trainees are authors and the FIC
award is cited in the acknowledgements.

U.S. Principal Investigators proposing competitive renewals
are encouraged to transfer additional leadership of the ongoing collaborative
training program to the developing country partner in the application.

Revision (formerly called supplement)Awards: Principal Investigators may apply for one competing
one-year revision award annually to an active FIC Global Infectious Disease
Research Training Program for the following purposes:

Supporting research training on
additional infectious diseases relevant to the collaborating country and;

Providing advanced re-entry support
for developing country participants, who have completed substantial mid-
to long-term research training, to establish independent research projects
at the developing country institution upon their return home.

The principal investigator for a competing
revision (formerly called supplement) application must be
the same as the Principal Investigator of the parent research training grant.
The time period for proposed competing revision (formerly called
supplement) activities may not exceed the parent research
training grant completion date. A competing revision (formerly called
supplement) application cannot be submitted until after parent
research training grant is awarded. Competing revision (formerly called
supplement) applications should include:

A one-page introduction with a
detailed explanation of the scientific and administrative relationship
between the competing revision (formerly called supplement) research
training proposed and the specific aims of the existing training award;

A brief progress report on the
training accomplished since the initiation of the training award;

A needs assessment for the proposed
training expansion;

A detailed training plan; and

A non-modular budget.

Planning Grants for Developing Country
Institutions:Developing country institutions may apply for a one-year
planning grant to develop a future infectious disease research-training program
with U.S. collaborators. Planning grants should propose the following types of
activities to organize and plan for a research-training program, and prepare
and assemble an application to submit for support of that program the following
year:

Consultation with U.S. and developing country faculty to:

Assess the specific
needs for infectious disease research training at the developing country
institution;

Define the short- and long-term training components to address the
specific needs for infectious disease research training at the developing
country institution in a stepwise plan;

Define their roles and institutional commitments in the
research-training program.

Targeted training of developing
country faculty to fill gaps in expertise directly related to their role
in the proposed program or in responsible conduct of research, human
subjects education and other research administration areas.

Training ethical review committee
members of developing country institutions to obtain certification related
to the U.S. Federal-Wide Assurance for the developing country institution.

Planning grant program director
training in grant writing.

Research Training Plan Page Limitations

Research training plans
should not exceed 25 pages.

Appendix
Materials

All paper PHS 398 applications submitted for May 25, 2008 and subsequent
due dates must provide
appendix material on CD only, and include five identical CDs in the same
package with the application. Paper applications submitted for due dates
prior to May 25, 2008 may voluntarily provide the appendix on five identical
CDs; if submitting CDs it is not necessary to include a paper appendix. (seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do
not use the Appendix to circumvent the page limitations of the Research Plan
component. An application that does not observe the required page limitations
may be delayed in the review process.

Resource Sharing
Plan(s)

The
following resource sharing policies do not apply to this FOA:

Data Sharing Plan. Not Applicable

Sharing Model Organisms. Not Applicable

Genome Wide
Association Studies (GWAS). Not Applicable

Specific
Instructions for Foreign Applications

All
foreign applicants must complete and submit budget requests using the Research
& Related Budget component found in the application package for this FOA.
See NOT-OD-06-096, August
23, 2006.

Section
V. Application Review Information

1.
Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria described below will be
considered in the review process.

2.
Review and Selection Process

Applications
that are complete will be evaluated for scientific and technical merit by an
appropriate peer review group convened by CSR and in accordance with NIH peer
review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.

As
part of the scientific peer review, all applications will:

Undergo a
selection process in which only those applications deemed to have the
highest scientific and technical merit, generally the top half of
applications under review, will be discussed and assigned a priority
score.

Receive a
written critique.

Receive a second level of review by the FIC national advisory council.

Applications
submitted in response to this funding opportunity will compete for available
funds with all other recommended applications submitted
in response to this FOA.The following will be
considered in making funding decisions:

Scientific
merit of the proposed project as determined by scientific peer review.

Availability
of funds.

Relevance
of the proposed project to program priorities.

The
goals of NIH supported research training are to advance our understanding of
biological systems, to improve the control of disease, and to enhance health.
In their written critiques, reviewers will be asked to comment on each of the
following criteria in order to judge the likelihood that the proposed research
training will have a substantial impact on the pursuit of these goals. Each of
these criteria will be addressed and considered in assigning the overall score,
and weighted as appropriate for each application. Note that an application does
not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a meritorious priority score. For example,
an investigator may propose to carry out important research training that by
its nature is not innovative but is essential to move a field forward.

Significance:Does the infectious disease research training proposed meet the
specific needs for infectious disease research expertise at the developing
country institution? Will the scientific contributions expected from the
proposed infectious disease research training result in public health benefits
for developing countries? What is the demonstrated capacity (for competing
renewal applications) or expected potential (for new applications) to achieve
independent and sustainable laboratory, clinical or public health infectious
disease research capacity through the proposed training efforts?

Approach:Are the
research training objectives clear and feasible? Will the research-training
plan achieve the proposed training objectives including:

A trainee recruitment
and selection process that captures the most qualified individuals who could
most benefit from the training proposed;

Culturally sensitive strategies to recruit an adequate representation of
women, ethnic minorities and socially disadvantaged groups among the developing
country trainees;

A process for matching trainees to appropriate mentors or instructors
and research projects or needed research skills to fill recognized gaps in
expertise at the developing country institution;

A process for scientific peer review of trainee research;

A plan to provide training in sustainable research enhancing areas such
as laboratory safety, responsible conduct of research, scientific writing,
grant writing, statistical methods, good clinical practice, medical
informatics, data management, management of intellectual property, and English
as a second language, if necessary;

A process for periodic evaluation of trainee progress in acquiring
academic and research skills;

Approaches to support post-training integration into infectious disease
research at the developing country institution;

A method to evaluate the long-term impact of the infectious disease
research training program on the subsequent careers of the trainees and the
infectious disease research capacity at the developing country institution?

For applications designating
multiple PDs/PIs, is the leadership approach, including the designated roles
and responsibilities, governance, and organizational structure, consistent with
and justified by the aims of the project and the expertise of each of the
PDs/PIs?

Innovation:Does
the research training proposed identify innovative strategies for trainees to
gain the skills needed to conduct infectious disease laboratory studies,
clinical or public health research studies or intervention trials relevant to
national health priorities conducted at the developing country institution?
Does the training program proposed employ an innovative training approach to
produce a critical mass of independent infectious disease researchers and
sustainable research training at the developing country institution? Does the
research training plan include the use of modern information technology to
facilitate trainee access to scientific information, distance learning and
collaborative scientific interaction?

Investigators:Are the
program director(s) (including multiple PD/PIs) qualified to lead and the U.S. and developing country faculty qualified to serve as research mentors in the proposed
training program? Does the collaboration between the U.S. and developing country investigators and their institutions provide a suitable framework for
the proposed training will occur? Is the research support of the program
director(s) (including multiple PD/PIs) and faculty relevant to the research
training proposed? For competing renewal applications, were previous research
training efforts made by applicants effective in training independent and
sustainable scientific career advancement for the participants in the proposed
developing country?

Environment:Are the
infectious disease teaching and research facilities and other resources, and
ongoing research support related to the overall training environment adequate
at the U.S. and developing country institutions? Are the U.S. and developing country institutional officials committed to the proposed infectious disease
research training program?

2.A.
Additional Review Criteria:

In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the rating:

Resubmission
Applications (formerly “revised/amended” applications): Are the responses to comments from
the previous scientific review group adequate? Are the improvements in the
resubmission application appropriate?

Training in Protection of Human
Subjects from Research Risk: The plans for training regarding the involvement of
human subjects and protections from research risk relating to their
participation in the proposed trainee research will be assessed (see the
Research Training Plan section on Human Subjects in the PHS 398 instructions).

Training in Inclusion of Women,
Minorities and Children in Research: Are the training plans
regarding the inclusion of subjects from both genders, all racial and ethnic
groups (and subgroups), and children appropriate for the scientific goals of
the trainee research adequate? See the Research Training Plan section on Human
Subjects in the PHS 398 instructions.

Training in Care and Use of
Vertebrate Animals in Research: If vertebrate animals are to
be used in the trainee projects, are plans for training in care and use of
animals in research adequate? See the “Vertebrate Animals Section” of the PHS398
Research Plan component of the SF424 (R&R).

Training in Biohazards:If
trainee research includes materials or procedures that are potentially
hazardous to research personnel and/or the environment, is the proposed
biosafety training provided adequate?

2.B.
Additional Review Considerations

Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.

Applications
from Foreign Organizations: Whether the project presents special opportunities
for furthering research programs through the use of unusual talent, resources,
populations, or environmental conditions in other countries that are not
readily available in the United States or that augment existing U.S. resources will be assessed.

2.C.
Resource Sharing Plan(s)

The
following resource sharing policies do not apply to this FOA:

Data Sharing Plan. Not Applicable

Sharing Model Organisms. Not Applicable

Genome Wide
Association Studies (GWAS). Not Applicable

3. Anticipated Announcement and Award
Dates

Not Applicable

Section
VI. Award Administration Information

1. Award Notices

After the peer review
of the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.

A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official (designated in
item 12 on the Application Face Page). If a grantee is not email enabled, a
hard copy of the NoA will be mailed to the business official.

Awardees are expected to maintain data regarding their
trainees in a trainee tracking system and report trainee publications and
significant accomplishments to FIC in a timely manner.

A final
progress report, invention statement, and Financial Status Report are required
when an award is relinquished when a recipient changes institutions or when an
award is terminated.

Section
VII. Agency Contacts

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:

Human Subjects Protection:Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Inclusion of Women And Minorities in Clinical
Research:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy continues
to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical
Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them. All investigators proposing research involving
human subjects should read the "NIH Policy and Guidelines" on the
inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject
Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH
Public Access Policy Requirement:In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html),
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public Access
webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable
Health Information:The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution reviewers
that their anonymity may be compromised when they directly access an Internet
site.

Healthy People 2010:The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This PA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and under Federal Regulations 42 CFR 4263a and 45 CFR Parts 74 and 92.
All awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

Loan Repayment Programs:NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.